Deep Brain Stimulation Effects in Dystonia

Dystonia Clinical Trial

Official title:

Deep Brain Stimulation Effects in Dystonia: Time Course of Electrophysiological Changes in Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04568681
• Other study ID #: IRB202002270
• Status: Completed
• Start date: November 5, 2020
• Est. completion date: July 12, 2022

Study information

• Verified date: July 2022
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Deep Brain Stimulation (DBS) is an effective therapy for patients with medically refractory primary dystonia. However, DBS programming for dystonia is not standardized and multiple clinic visits are frequently required to adequately control symptoms. We aim to longitudinally record brain signals from patients using a novel neurostimulator that can record brain signals. We will correlate brain signals to clinical severity scores to identify pathological rhythms in the absence of DBS, and we will study the effects of DBS on these signals in order to guide clinical programming. We are going to recruit patients who receive the Medtronic Percept device, which allows for brain signal recordings (this feature is FDA approved). The investigators will be conducting an observational study using this device to collect data that the subjects receive as standard of care.

Description:

The development of newer technologies has allowed clinicians and researchers to better understand pathophysiological underpinnings of different disorders managed with neuromodulation. There is a paucity of information, however, on dystonia, likely due to its rarity of cases and variability in phenomenology to allow generalization of findings. Possible abnormal brain signals, such as high activity in theta band (defined as rhythms in the 4-12Hz range ), have been proposed by small case series. The development of newer technologies has allowed clinicians and researchers to better understand pathophysiological underpinnings of different disorders managed with neuromodulation. There is a paucity of information, however, on dystonia, likely due to its rarity of cases and variability in phenomenology to allow generalization of findings. Possible abnormal brain signals, such as high activity in theta band (defined as rhythms in the 4-12Hz range ), have been proposed by small case series

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: July 12, 2022
• Est. primary completion date: July 12, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient gives an informed consent.
• Patient is over 18 years of age.
• Having a diagnosis of a primary dystonia confirmed by a trained movement disorders neurologist;
• Having failed or not tolerated conventional medical management, at the discretion of the neurologist managing the patient;

Exclusion Criteria:

• Having alternative diagnoses to a primary dystonic syndrome;
• Having comorbid neurodegenerative disorders that may affect mobility or cognition (e.g. comorbid Parkinson's disease);
• Having sequelae of prior brain insult (e.g. prior stroke or brain tumor);
• History of prior resectivebrain surgery (e.g. tumor resection);
• Not being a DBS candidate;
• Selection of alternative targets to conventional GPi;
• Receiving unilateral implants
• Having a higher surgical risk that precludes patient from having standard intraoperative mapping.

Related Conditions & MeSH terms

• Dystonia
• Dystonic Disorders

Intervention

Device:
• Deep brain stimulation (DBS)
Deep brain stimulation is an FDA approved therapy that involves surgical implantation of electrodes in deep brain targets and an implantable pulse generator delivers electrical pulses.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unified Dystonia Rating Scale (UDRS)	A clinical scale fo dystonia severity (0-4, 0:no symptoms, 4:extreme)	12 months
Primary	Burke-Fahn-Marsden Dystonia Rating Scale	A clinical scale fo dystonia severity (0-4, 0:no symptoms, 4:extreme)	12 months
Primary	Toronto Western Spasmodic Torticollis Rating Scale	A clinical scale of dystonia severity (0-4, 0:no symptoms, 4:extreme)	12 months